Post-approval appending of CSARs to drug package inserts: an analysis of the types of adverse reactions and time to addition

Tamura Norio; Ishiguro Chieko; Matsuda Tsutomu

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Post-approval appending of CSARs to drug package inserts: an analysis of the types of adverse reactions and time to addition

机译：批准后将CSAR附加到药品包装说明书中：不良反应类型和添加时间的分析

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PurposeThe aim of this study was to quantitatively analyze clinically significant adverse reactions (CSARs) added to drug package inserts after approval and to investigate the time to these post-approval additions as an indicator of safety-related regulatory actions.

机译：目的本研究的目的是定量分析批准后添加到药物包装说明书中的临床重大不良反应（CSAR），并调查批准后添加这些药物的时间，以作为安全相关监管措施的指标。

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《Pharmacoepidemiology and drug safety》 |2015年第2期|共10页
作者
Tamura Norio; Ishiguro Chieko; Matsuda Tsutomu;
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原文格式 PDF
正文语种 eng
中图分类药学;
关键词
unknown risk; pharmacovigilance; drug safety; adverse event; safety-related regulatory actions; post-approval analysis; pharmacoepidemiology;

机译：未知风险;药物警戒;药物安全性;不良事件;与安全有关的管制措施;批准后分析;药物流行病学;

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1. Post-approval appending of CSARs to drug package inserts: an analysis of the types of adverse reactions and time to addition [J] . Tamura Norio, Ishiguro Chieko, Matsuda Tsutomu Pharmacoepidemiology and drug safety . 2015,第Pta2期

机译：批准后将CSAR附加到药品包装说明书中：不良反应类型和添加时间的分析
2. A study of clinical information of various package inserts: an approach to encourage adverse drug reaction reporting and emphasis on black box warning [J] . Ervilla Dass International Journal of Basic & Clinical Pharmacology . 2018,第7期

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3. Adverse events caused by drug interactions involving glucuronoconjugates of zidovudine, valproic acid and lamotrigine, and analysis of how such potential events are discussed in package inserts of Japan, UK and USA. [J] . Hirata-Koizumi M, Saito M, Miyake S, Journal of Clinical Pharmacy and Therapeutics . 2007,第2期

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4. Discovering Adverse Drug Reactions from Twitter: A Sentiment Analysis Perspective [C] . Luiz A. P. A. Ribeiro, Daniel Cinalli, Ana Cristina Bicharra Garcia International Conference on Computer Supported Cooperative Work in Design . 2021

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5. Involvement of Th17 Pathway in Adverse Drug Reactions: Mechanistic Investigation of Drug-Induced Autoimmunity and Drug-induced Liver Injury. [D] . Zhu, Ervin Xu. 2012

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6. Ontology-based systematical representation and drug class effect analysis of package insert-reported adverse events associated with cardiovascular drugs used in China [O] . Liwei Wang, Mei Li, Jiangan Xie, -1

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7. Comparison of Adverse Drug Reaction Rates in the Package Insert at the Time of New Drug Approval and at Re-Examination [O] . Tatsuya WATANABE, Mami IWASAKI, Atsushi UJIHARA, 2013

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Post-approval appending of CSARs to drug package inserts: an analysis of the types of adverse reactions and time to addition

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